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Completed

NCT Number: NCT00465231

Preventive Analgesia in Multiparas Undergoing Induction of Labour

Our study is about providing a better birthing experience by placing and initiating epidural for labour pain before the contractions start. This concept of prevention of pain before its onset is known as preventive - or preemptive -pain management and is well known in surgical and anaesthetic practice. We believe that the use of preventive epidural analgesia will improve the quality of labour epidurals, increase maternal satisfaction and reduce the stress response to labour and delivery.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

Labour induces a well-documented stress response in both mother and fetus. Pain, anxiety and stress associated with labour result in the activation of the sympathetic nervous system, which increases plasma catecholamine concentrations with a resultant increase in cardiac output, peripheral vascular resistance and eventually, reduction in utero-placental perfusion. One aspect that has not been addressed in the literature is the role of preventive analgesia in labour. We believe that the use of preventive epidural analgesia will improve the quality of labour pain, increase maternal satisfaction and reduce the stress response in labour.

The multiparous parturients that are scheduled for elective inductions of labour will be offered preventive epidural analgesia. Upon placing the epidural, patients will receive, in a double blind fashion, one of two possible epidural drug regimens, which are a saline placebo or 0.0625% bupivacaine with 2 micrograms of fentanyl per millilitre. The patient then undergoes routine induction and management of labour. At any point after induction of labour, patients in either group can request analgesia. Upon request for analgesia the standard epidural loading dose and infusion with PCEA is initiated. The primary outcome will be the success of analgesia (Verbal Analogue Scale of 3 or less) during the first stage of labor, from first request of epidural analgesia to full dilatation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Multiparous patients who had previous vaginal delivery, undergoing induction of labour
  • Singleton Pregnancy

Exclusion criteria

  • Morbid Obesity
  • Patients who have received cortisol, opioids or sedatives within the last 24 hours

Treatment and study plan

Bupivacaine, fentanyl

Drug

10mL of 0.0625% of bupivacaine plus fentanyl 2 mcg/ml

preservative free saline

Drug

10mL saline solution

Primary outcomes

  1. Pain scores (VAS) remain 3 or less

    Time frame: throughout the first stage of labor

Secondary outcomes

  1. Bupivacaine consumption

    Time frame: during labour

  2. Urinary creatinine to cortisol ratio

    Time frame: during labour

  3. Neonatal outcome

    Time frame: at delivery

  4. Obstetric outcome

    Time frame: at delivery

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Preventive Analgesia in Labour:A Randomised, Placebo-Controlled Study in Multiparas Undergoing Induction of Labour

Important dates

Study start
2007
Study completion
2007
First posted
Apr 24, 2007
Registry last updated
Dec 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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